Full text of "USPTO Patents Application 10687850"

See other formats

WORLD INTELLECTUAL PROPERTY ORGANIZATION
International Bureau

PCT

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)

(51) International Patent Classification 7 J
G01N 33/52, BOIL 3/00

(11) International Publication Number:
(43) International Publication Date:

WO 00/33074

8 June 2000 (08.06.00)

(21) International Application Number: PCT/US99/273 1 1

(22) International FUing Date: 17 November 1999 (17.11.99)

(30) Priority Data:

60/110,331

30 November 1998 (30.1 1 .98) US

(71) Applicant: ABBOTT LABORATORIES [US/US];

CHAD-0377/AP6D-2, 100 Abbott Park Road, Ab-
bott Park, IL 60064-6050 (US).

(72) Inventors: LEWIS, Mark, E.; 39 Lovers Lane, Groton,

MA 01450 (US). CARAYANNOPOULOS, Leonidas;
Apartment 2, 929 Broadway, Somerville, MA 02144 (US).
PARKS, Joel, M.; 13 Ledgewood Drive, Bedford, MA
01730 (US). AMES, William; 141 Lovell Road, Holden,
MA 01520 (US).

(74) Agents: WEINSTEIN, David, L. et al.; Abbott Laboratories,
CHAD 0377/AP6D-2, 100 Abbott Park Road, Abbott Park,
IL 60064-6050 (US).

(81) Designated States: AE, AL, AM, AT, AU, AZ, BA, BB, BG,
BR, BY, CA, CH, CN, CR, CU t CZ, DE, DK, DM, EE,
ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP,
KE t KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA,
MD, MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU,
SD, SE, SG, SI, SK, SL, TJ, TM, TO, TT, TZ, UA, UG,
UZ, VN, YU, ZA, ZW, ARIPO patent (GH, GM, KE, LS,
MW, SD, SL, SZ, TZ, UG, ZW), Eurasian patent (AM, AZ,
BY, KG, KZ, MD, RU, TJ, TM), European patent (AT, BE,
CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC,
NL, PT, SE), OAPI patent (BF, BJ, CF, CG, CI, CM, GA,
GN, GW, ML, MR, NE, SN, TD, TG).

Published

With international search report.

Before the expiration of the time limit for amending the
claims and to be republished in the event of the receipt of
amendments.

(54) Title: MULTICHEMISTRY MEASURING DEVICE AND TEST STRIPS
(57) Abstract

A multichemistry measuring device and diagnostic test strips which, in combination
with the multichemistry measuring device, provide a multichemistry testing system are
disclosed. The test strips are for chemical analysis of a sample, and are adapted for use
in combination with a measuring device having a test port and capable of performing a
multiplicity of testing functionalities. Each type of test strip corresponds to at least one
of the testing functionalities, and at least some types of test strips have indicators of the
testing functionality on them. The test port is adapted for use in combination with a
multiplicity of different types of test strips and includes a sensor capable of specifically
interacting with the indicators) on the test strips, thereby selecting at least one of the
multiplicity of testing functionalities corresponding to the type of test strip.

FOR THE PURPOSES OF INFORMATION ONLY
Codes used to identify States party to the PCT on the front pages of pamphlets publishing international applications under the PCT.

Albania

Spain

Lesotho

Slovenia

Armenia

Finland

Lithuania

Slovakia

Austria

France

Luxembourg

Senegal

Australia

Gabon

Latvia

Swaziland

Azerbaijan

United Kingdom

Monaco

Chad

Bosnia and Herzegovina

Georgia

Republic of Moldova

Togo

Barbados

Ghana

Madagascar

Tajikistan

Belgium

Guinea

The former Yugoslav

Turkmenistan

Burkina Paso

Greece

Republic of Macedonia

Turkey

Bulgaria

Hungary

Mali

Trinidad and Tobago

Benin

Ireland

Mongolia

Ukraine

Brazil

Israel

Mauritania

Uganda

Belarus

Iceland

Malawi

United States of America

Canada

Italy

Mexico

Uzbekistan

Central African Republic

Japan

Niger

Viet Nam

Congo

Kenya

Netherlands

Yugoslavia

Switzerland

Kyrgyzstan

Norway

Zimbabwe

C6te d*Ivoire

Democratic People's

New Zealand

Cameroon

Republic of Korea

Poland

China

Republic of Korea

Portugal

Cuba

Kazakstan

Romania

Czech Republic

Saint Lucia

Russian Federation

Germany

Liechtenstein

Sudan

Denmark

Sri Lanka

Sweden

Estonia

Liberia

Singapore

WO 00/33074

PCT/US99/273U

MULTICHEMISTRY MEASURING DEVICE AND TEST STRIPS

This application claims priority from the provisional application Serial No.
60/110,331, filed November 30, 1998.

Cross-reference to Related Applications

This application is a co-pending application of an application filed on
evendate herewith, having a docket number of 6621. US. 01, and entitled
ANALYTE TEST INSTRUMENT HAVING IMPROVED CALIBRATION AND
COMMUNICATION PROCESSES, the contents of which are incorporated herein
by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to measuring devices for performing assays for the
accurate determination of the presence, concentration, or activity of one or more
analytes in a sample applied to test strips adapted for use with the devices. The
measuring devices and test strips of the invention are particularly useful in the
fields of clinical chemistry, environmental testing, and chemical process control.

WO 00/33074

PCT/US99/2731 1

2. Discussion of the Art

Electrochemical measuring devices that detect the presence,
concentration, or activity of one or more analytes in a solution are well known in
5 the art. In addition, disposable electrochemical test strips adapted for use with
such devices are known in the art. For example, test strips are disclosed in U.S.
Patent No. 5,628,890; strip electrodes with screen printing are disclosed in U.S.
Patent No. 5,509,410; and additional strip electrodes with screen printing are
disclosed in U.S. Patent No. 5,682,884. In such devices, a sample is applied to

10 the test strip, and the test strip is inserted into a port on the measuring device.
Such measuring devices and test strips are commercially available for home use
by diabetics for the measurement of blood glucose (e.g., the PRECISION QID
blood glucose testing system manufactured and sold by MEDISENSE, Inc.,
Waltham, MA). Other devices are commercially available, for use by home users

15 or clinicians, for the electrochemical measurement of other blood analytes and
parameters, such as lactate or urea. However, in the prior art, the measurement
of multiple analytes or parameters in a sample typically requires the use of
multiple measuring devices, each adapted for a different testing functionality, or
a single measuring device in which the user must manually switch the device

20 between different testing functionalities.

There is, therefore, a need in the art for products and methods by which a
user may perform a multiplicity of different assays with a single measuring device
having a multiplicity of testing functionalities, but without having to manually
reconfigure or switch between different functionalities of the device, and, without

25 the need for a complex or expensive port or test strip design.

WO 00/33074

PCT/US99/273H

SUMMARY OF THE INVENTION

The present invention provides a multichemistry measuring device and
. diagnostic test strips which, in combination with the multichemistry measuring

5 device, provide a multichemistry diagnostic testing system. The system enables
a user to perform a multiplicity of different measurements on a sample by
choosing one of a multiplicity of types of test strips, applying an amount of the
sample to the test strip, inserting the test strip into a port of the measuring
device, and receiving the test results from the device. The test strips and the

10 port are adapted such that each type of test strip bears an indicator that is -
recognized by the port and that indicates to the measuring device which testing
functionality is to be utilized. Therefore, the user is not required to manually
reconfigure or switch the device between different functionalities, and a single
port and a single measuring device may be employed with a multiplicity of

15 different types of test strips.

Thus, in one aspect, the invention relates to diagnostic test strips for
analysis of a sample. The diagnostic test strips are adapted for use in
combination with a measuring device having a test port. The measuring device
is capable of performing a multiplicity of testing functionalities. In this aspect, the

20 test strip comprises a support capable of releasably engaging the test port; at
least one reaction area on the support for receiving the sample; and an indicator
capable of interacting with the test port to select at least one of the multiplicity of
testing functionalities of the measuring device. In one embodiment, the indicator
comprises one or more electrically conductive contacts capable of engaging at

25 least two electrically conductive pins within the test port. In such an

embodiment, the electrically conductive contacts close at least one circuit
between the at least two electrically conductive pins within the test port. In
preferred embodiments, the electrically conductive indicator comprises a material
selected from: carbon, gold, silver, platinum, nickel, palladium, titanium, copper,

WO 00/33074

PCT/US99/2731 1

or lead. In preferred embodiments, the electrically conductive contacts comprise
an electrically conductive printable ink. In another embodiment, the indicator
comprises one or more projections or depressions capable of mechanically
engaging one or more pins within the test port. In such an embodiment, the
5 mechanical displacement of at least one of the pins results in the opening or
closing of at least one circuit. In another embodiment, the indicator comprises
an optically detectable pattern capable of signaling to or being detected by an
optical detector in the test port. In preferred embodiments, the optically
detectable indicator comprises a pattern formed by a printable ink.

10 In another aspect, the present invention provides a test port for use in a

measuring device that is capable of performing a multiplicity of testing
functionalities and is adapted for use in combination with a multiplicity of different
types of diagnostic test strips. Each type of test strip corresponds to at least one
of the testing functionalities of the device, and at least some types of test strips

15 have indicators of the testing functionality on them. In this aspect, the test port
comprises a sensor capable of specifically interacting with the indicator(s) on the
test strips, thereby selecting at least one of the multiplicity of testing
functionalities corresponding to the type of test strip. In one embodiment, the
indicators on the test strips are electrically conductive, and the sensor of the test

20 port comprises a multiplicity of electrically conductive pins. In such an

embodiment, at least two of the pins can be bridged by an indicator, thereby
closing an electrical circuit. In another embodiment, the indicators on the test
strips comprise projections or depressions, and the sensor of the test port is a
pin that may be physically displaced by or into the indicators, thereby opening or

25 closing an electrical circuit. In another embodiment, the indicators comprise an
optically detectable pattern, and the sensor of the test port is an optical sensor.

In another aspect, the invention provides a measuring device having a
multiplicity of testing functionalities for chemical analysis. The device is adapted
for use in combination with a multiplicity of different types of test strips. Each of

30 the types of test strips corresponds to at least one of the testing functionalities,

WO 00/33074

PCT/US99/273U

and at least some of the types of test strips have indicators of the testing
functionality on them. The device includes: a test port including a sensor
capable of interacting with the indicators on the test strips to select at least one
of the multiplicity of testing functionalities; and a multiplicity of test circuitries for
5 specifically measuring reactions on the test strips, the reactions corresponding to
the multiplicity of testing functionalities.

, In some embodiments, the assay may detect the presence, concentration,
or activity of one or more of the following in a sample: L-amino acids, alcohols,
aldehydes, ketones, urea, creatinine, xanthines, sarcosine, glucolate, pyruvate,

10 lactate, fructosamine, methylamine, carbon monoxide, cholesterol, hemoglobin,
glycated hemoglobin, microalbumin, high density lipoproteins, low density
lipoproteins, and glucose.

In some embodiments, the reaction area includes one or more reagents
adsorbed to the support. The reagents are capable of reacting with an analyte in

15 the sample. In preferred embodiments, the reagent is selected from, but not
limited to, one of the following: glucose oxidase, lactate dehydrogenase,
peroxidase, and galactose oxidase.

In some embodiments, the test strip further comprises a multiplicity of
electrically conductive testing contacts capable of transferring current between

20 the reaction area and the measuring device. In certain of these embodiments,
the testing contacts are located on a first major surface of the test strip, and the
indicator contacts are located on a second major surface of the test strip. In
other embodiments, the testing contacts and indicator contacts are located on
the same major surface of the test strip. In preferred embodiments, the testing

25 contacts comprise a conductive material selected from, but not limited to, carbon,
gold, silver, platinum, nickel, palladium, titanium, copper, or lead.

WO 00/33074

PCT/US99/2731 1

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts possible configurations of electrically conductive indicators
for five different types of test strips, adapted for use with a test port having three
5 pins.

FIG. 2 depicts possible configurations of mechanical indicators for four
different types of test strips, adapted for use with a test port having two pins.

FIG. 3 depicts possible configurations of optically detectable indicators for
four different types of test strip, adapted for use with a test port detecting optical
10 characteristics at two locations.

FIG, 4 depicts a side cut-away view of a test port and test strip in which
the indicators are electrically conductive.

FIG. 5 depicts a side cut-away view of a test port and test strip in which
the indicators are mechanical.

DETAILED DESCRIPTION OF THE INVENTION

The invention provides measuring devices for performing assays for the
accurate determination of the presence, concentration, or activity of one or more

20 analytes in a sample applied to test strips adapted for use with the devices. The
multichemistry measuring device and test strips of the invention have particular
utility in fields including, but not limited to, clinical chemistry, chemical process
control, and environmental testing. For example, the multichemistry measuring
device and test strips can be used in clinical chemistry to determine the levels of

25 particular analytes (e.g., glucose, cholesterol, urea, creatinine) in body fluids
(e.g., whole blood, serum, urine), in environmental testing to determine the
presence or concentration of pollutants (e.g., PCBs) or biohazards (e.g.,
bacteria, virus), or in chemical process control for monitoring the progress of a

WO 00/33074

PCT/US99/2731 1

process by detecting the presence, concentration, or activity or various adducts,
edducts,or other parameters (e.g., pH, salinity).

In particular, the present invention provides methods and products for use
therewith by which a user may perform a multiplicity of different assays with a
5 single measuring device having a multiplicity of testing functionalities, but without
the need for manually reconfiguring or switching between different functionalities
of the device. By eliminating the need for the user to manually set the device
when changing from one test to another, the present invention provides for
increased convenience and speed of use, and reduces the likelihood of human

10 error. To achieve these ends, the invention employs a multichemistry test port
that is capable of recognizing various diagnostic test strips having different
testing functionalities. Each type of diagnostic test strip comprises a different -
indicator (or indicators) that enable the test port to differentiate it from other types
of diagnostic test strips. When the user inserts the test strip into the test port,

15 the test port will identify the corresponding functionality of the device and
automatically reconfigure or switch the measuring device to the appropriate
functionality.

In one embodiment, the overall system comprises an electrochemical
measuring device comprising a multichemistry test port in electrical

20 communication with a multiplicity of different testing functionalities. The test port
is capable of releasably engaging various diagnostic test strips having different
testing functionalities. The diagnostic test strip comprises at least two test
electrodes (a reference electrode and a working electrode) and a reaction area.
When a fluid sample is added to the reaction area, the sample brings the

25 reference electrode into electrical communication with the working electrode.
When a diagnostic test strip is releasably engaged in the test port, the working
electrode and the reference electrode are brought into electrical communication
with at least one of a multiplicity of circuits corresponding to the different testing
functionalities of the measuring device. The indicators on the test strip

WO 00/33074

PCT/US99/27311

determine which of the multiplicity of circuits corresponding to the different
testing functionalities of the measuring device is activated and employed.

Diagnostic Test Strips

At minimum, the test strips of the invention comprise a support, which
receives the sample and releasably engages the test port. The support bears
one or more indicators that correspond to the testing functionality of the test
strip. The support can be produced from materials including, but not limited to,
PVC or other plastics, ceramic materials, or printed-circuit-board laminates. In
preferred embodiments, the support is substantially flat and elongated with the
indicators at or near a first end, and a reaction area at or near a second end.

In preferred embodiments, the assay to be performed is electrochemical
in nature, and the test strip further comprises electrically conductive testing
contacts in electrical communication with the reaction area and extending toward
the first end. In such embodiments, the testing contacts are capable of
transferring current between the reaction area and the measuring device. The
testing contacts can be composed of, but are not limited to, conductive materials,
such as, for example: carbon, gold, silver, platinum, nickel, palladium, titanium,
copper, and lead.

In general, the reaction area in such embodiments typically comprises a
conductive electrode coated with a mixture of a catalytically active enzyme and
an optional mediator compound, and is preferably further coated or covered by a
permeable retaining membrane. The enzyme and optional mediator compound
can be coated in separate layers. When such a coated electrode is contacted
with a sample containing an analyte for which the enzyme exerts a catalytic
effect, the analyte of interest passes through the permeable retaining membrane
and reacts with the enzyme and mediator compound (when present) to produce
an activated form of the mediator compound. The activated mediator compound
transfers electrons to the electrode to produce a signal, which is correlated with
the concentration of the analyte. In other embodiments, a mediator compound is

WO 00/33074

PCT/US99/273U

not necessary, and the reaction between an analyte and an enzyme produces a
product (e.g., hydrogen peroxide) that is capable of transferring electrons to the
electrode. Thus, in one particular embodiment, the analyte may be glucose and
the catalytically active enzyme may be glucose oxidase, and the measuring
device and test strips of the invention may be used to ascertain the
concentration of glucose in a fluid sample such as blood. In a second particular
embodiment, the analyte may be lactate and the catalytically active enzyme may
be lactate dehydrogenase, and the measuring device and test strips of the
invention may be used to ascertain the concentration of lactate in blood.
However, in these different particular embodiments, the measuring device must
employ different testing functionalities or circuitries with the different test strips.
Therefore, it is vital to the proper functioning of the system that the measuring
device perform the correct testing functionality when a particular type of test strip
is inserted into the multichemistry test port.

As stated previously, the invention provides a multiplicity of test strips
capable of performing a multiplicity of diagnostic tests, but which can be used
with a single measuring device having a single test port, without the need for
manual reconfiguration or switching between different testing functionalities of
the device. The invention provides for indicators on the test strips, which
indicators can be recognized by a sensor within the multichemistry test port in
order to ascertain the testing functionality that the measuring device should • . ..
perform. For the purposes of this invention, the term "indicator" refers to any
pattern of information capable of being recognized by the test port, including the
absence of any discernible pattern (i.e., a "null" pattern). The types of indicators
employed in the present invention include, but are not limited to, mechanical,
electrical, and optical indicators, as well as any combinations thereof.

In a particularly preferred embodiment, the indicators comprise electrically
conductive patterns on a major surface of a test strip. In this embodiment, when
the test strip releasably engages the test port, the indicator comes into contact
with a plurality of electrically conductive pins in the test port. Depending upon

WO 00/33074

PCTAJS99/2731 1

the pattern of the indicator, a circuit between one or more pairs of the pins may
be closed or "shorted" by the conductive material of the indicator. The
measuring device detects which circuits, if any, are closed by insertion of the test
strip, and selects the testing functionality appropriate for that type of test strip.
5 In an alternative embodiment, the indicator comprises a pattern of

projections or bumps on a major surface of the test strip, and the test port
includes a plurality of pins that can mechanically engage the indicator portion of
the test strip. When inserted into the test port, the projections of the indicator
may physically displace one or more of these pins. In one embodiment, the pin
10 or pins may be displaced such that they are brought into electrical

communication with one or more conductive elements, thus closing one or more
circuits. In another embodiment, the pin or pins may be in electrical
communication with one or more conductive elements before insertion of the test
strip, and may be displaced by the indicator upon insertion into the test port, thus
15 opening one or more circuits. The measuring device detects which circuits have
been opened or closed by insertion of the test strip, and selects the testing
functionality appropriate for that type of test strip. In a related embodiment, the
indicator may comprise a pattern of indentations or holes (rather than projections
or bumps) in the test strip. In such an embodiment, the test port includes a
20 plurality of pins, which pins mechanically engage the indicator portion of the test
strip and are displaced in the absence of a indentation or hole. Thus, pins that
are brought into register with the indentations or holes fail. to be displaced by the
insertion of the test strip into the test port, and, just as the pattern of
displacement of pins by projections conveys information, the pattern of non-
25 displacement by indentations conveys information and serves to identify the type
of test strip and its functionality.

In another embodiment, the indicator comprises an optically detectable
pattern printed on a major surface of the test strip. Again, for the purposes of
this invention, the absence of a printed pattern may also serve as an indicator.
30 In one embodiment, the pattern may consist of regions that exhibit higher or

WO 00/33074

PCT/US 99/2731 L

lower reflectivity or absorbance, and the major surface of the test strip may serve
as part of the pattern (e.g., by providing a background reflectivity or absorbance
that differs from that of a pattern printed in ink). Alternatively, the indictor may
comprise patterns of different colors, or may even comprise characters. In all
5 cases, when the test strip is inserted into the test port, optical sensors within the
test port recognize the pattern and cause the measuring device to select the
testing functionality appropriate to that type of test strip.

Multichemistrv Test Ports

In general, the multichemistry test port serves as an interface between the
10 test strip and the measuring device. Therefore, for measuring devices
performing electrochemical assays on samples on test strips, the test ports
typically comprise two or more testing pins, which are in electrical communication
with the measuring device. When a test strip engages the test port, the testing
pins are brought into electrical communication with the test electrodes (i.e., the
15 reference electrode and working electrode) located on the test strip. The present
invention, however, provides for additional sensors within the test port, which
sensors can recognize different types of test strips and cause the multichemistry
measuring device to switch between different testing functionalities to select the
testing functionality that is appropriate for the type of diagnostic test desired.
20 Thus, the test port is capable of detecting an indicator on a test strip and

causing the measuring device to select from among a multiplicity of testing
functionalities the functionality that is appropriate for the type of diagnostic test
desired.

In a preferred embodiment, the sensor comprises a multiplicity of
25 electrically conductive pins, which may be brought into electrical communication
with electrically conductive printed patterns on a test strip when the test strip
engages the test port. The electrically conductive pattern may close a. circuit
between one or more of the pins, or may be a "null" pattern, which does not
electrically bridge any of the pins. Depending on which circuits are closed and

WO 00/33074

PCT/US99/2731 1

which remain open, the measuring device selects the appropriate testing
functionality to perform on the test strip that has been inserted into the test port.

In another embodiment, the sensor comprises one or more pins that may
be mechanically engaged by an indicator when a test strip engages the test port.
In such an embodiment, the indicator comprises a pattern of one or more
projections or bumps capable of displacing one or more pins upon insertion of
the test strip into the test port. Alternatively, the indicator comprises a pattern of
one or more indentations or holes, which fail to displace one or more pins upon
insertion of the test strip into the test port. The displacement, or non-
dispiacement of these pins, may cause the opening or closing of one or more
circuits. In these embodiments, the measuring device selects the appropriate
testing functionality according to the pattern of displacement of the pins, and the
resultant opening or closing of circuits.

In another embodiment, the sensor comprises one or more optical
sensors capable of measuring light absorbance and reflectivity. In such an
embodiment, each sensor measures the absorbance, reflectivity, or color, or
identifies a character, at different portions of the indicator region when the test ;
strip is engaged in the test port. Depending upon the readings returned by the
sensors, the measuring device selects the appropriate testing functionality to
perform on the test strip.

Reaction Areas and Circuitries

The chemical assays performed by the test strips and measuring devices
of the present invention, along with the test strip reaction areas and associated
measuring device circuitries, may be adapted or selected from any of those
already known to those of skill in the art.

In preferred embodiments, the chemical assays are electrochemical
assays utilizing enzyme electrodes, and the reaction area comprises a working
electrode, a reference electrode, and an enzyme that reacts with the analyte to
be measured. In such embodiments, the working electrode may further

WO 00/33074

PCT/US99/27311

comprise a mediator (e.g., ferrocene) capable of transferring electrons between
the enzyme-catalyzed reaction and the working electrode. In some
embodiments, the reaction area further comprises a dummy electrode, in which
the dummy electrode includes the mediator but not the enzyme.

In preferred embodiments, when the test strip engages the multichemistry
test port, the working and reference electrodes are put in electrical
communication with the measuring device. When the sample is added to the
reaction area (before or after inserting the test strip in the test port), the sample
bridges the two electrodes, putting them in electrical communication with each
other, closing a circuit, and placing the sample in electrical communication with
the measuring device. In some embodiments, one of the testing functionalities
of the measuring device measures current through this circuit or a change in
voltage potential. In other embodiments, one of the testing functionalities of the
measuring device applies current to this circuit and measures resistance. The
use of such systems to determine presence and concentration of analyte is
discussed in, for example, U.S. Patent No. 4,545,382, and U.S. Patent No.
4,71 1 ,245. A sensor system that detects current that is representative of a
compound in a liquid mixture featuring a test strip adapted for releasable
engagement to signal readout circuitry is discussed in U.S. Patent No.
5,509,410.

In preferred embodiments, the invention is used in clinical chemistry to
determine the concentrations of several different analytes in a patient's blood. In
particular embodiments, the invention may be used to determine, for example, a
patient's blood glucose level, blood lactose level, and blood carbon monoxide
level in quick succession. In these embodiments, one or more assays will
require one or more different types of test strips, which, in turn, require different
testing functionalities to be utilized by the measuring device with the different
types of test strips. More than one assay may, of course, be conducted with a
single test strip. Because each type of test strip of the present invention has an

WO 00/33074

PCT/US99/2731 1

indicator which selects the correct testing functionality, no human intervention is
required to select the correct testing functionality for the different assays.

In other embodiments, the invention can be used in chemical process
control to ensure that the concentrations of various reactants or products, or
other chemical reaction parameters such as pH or salinity, are within certain
predefined tolerances at various stages of the process.

In other embodiments, the invention can be used in environmental testing.
In particular embodiments, the invention. can be used to test water quality. In
one further embodiment, the invention can be used to detect the presence and
amount of various pollutants such as sulfuric acid in rainwater. In other
embodiments, the invention can be used to detect the presence and amount of
various pollutants in oceans, lakes, ponds, streams, and rivers. In yet other
embodiments, the invention can be used to measure the amounts of certain
analytes such as chlorine in a swimming pool.

EXAMPLES

Differentiating Two Types of Test Strips

In one embodiment, the multichemistry measuring device is capable of
performing two separate electrochemical assays for measuring two different
analytes, for example, glucose and lactate, present in a blood sample.
Accordingly, the multichemistry test port is capable of recognizing two different
types of test strips. The first type of test strip is capable of assaying for glucose
and has glucose oxidase incorporated into its working electrode. The second
type of test strip is capable of assaying for lactate and has lactate
dehydrogenase incorporated into its working electrode. Each type of test strip

WO 00/33074

PCT7US99/27311

requires a unique electrochemical protocol that cannot be used with the other
type of test strip.

The multichemistry test port has two electrically conductive indicator
contacts that contact the bottom major surface of a test strip when the test strip
is releasably engaged in the test port. The test strip is elongate and has a top
major surface and a bottom major surface. The test strip for testing lactate has
an indicator comprising a pattern made from an electrically conductive ink printed
on the bottom major surface of the test strip. When a test strip for testing lactate
is releasably engaged in the multichemistry test port, the electrically conductive
indicator closes a circuit between the two electrically conductive indicator
contacts, causing the multichemistry measuring device to perform an
electrochemical assay for lactate. Conversely, the test strip for testing glucose
does not possess an electrically conductive indicator capable of closing the
circuit such that, when a test strip for testing glucose is releasably engaged in
the multichemistry testing port, the circuit between the two electrically conductive
indicator contacts remains open. When the circuit between the multichemistry
test port's two electrically conductive indicator contacts remains open, the
multichemistry measuring device performs an electrochemical assay for glucose.

Differentiating Five Types of Test Strips

In the previous example, a test port having two electrically conductive pins
allowed for recognition of two alternative types of test strips having different
functionalities. In this example, the use of three electrically conductive pins
allows for recognition of five different types of test strips having different
functionalities. As in the previous example, the test strip is elongate and has a
top major surface and a bottom major surface. A pattern of electrically
conductive ink is printed on the bottom major surface of the test strip. The test

WO 00/33074

PCT/US99/27311

port has three electrically conductive pins that come into contact with the printed
pattern on the bottom major surface of the test strip when the test strip is
reieasably engaged in the test port.

The possible configurations of the printed pattern are illustrated in FIG. 1.
In configuration A, there is no electrically conductive material present, and the
indicator is "null." Thus, none of the circuits among the pins are closed by
engaging the test strip within the test port. In configuration B, the electrically
conductive indicator pattern shorts pins 1 and 2, thereby closing the circuit
between these pins. In configuration C, the electrically conductive indicator
pattern shorts pins 1 and 3, thereby closing the circuit between these pins. In
configuration D, the electrically conductive indicator pattern shorts pins 2 and 3,
thereby closing the circuit between these pins. Finally, in configuration E, the
circuits between all three pins are closed.

In general, a test port with N electrically conductive pins can recognize 2 N
- N different configurations of indicators.

FIG. 4 depicts a cross section of a side view of a test port 400 engaged
with a test strip 420 having electrically conductive indicators. The test port 400
includes electrically conductive pins 440 that are brought into electrical
communication with the bottom major surface of test strip 420 when the test strip
420 is reieasably engaged in the test port 400. The test port 400 also includes
assay electrodes 460 that are (Drought into electrical communication with the top
major surface of the test strip 420 when the test strip 420 is reieasably engaged
in the test port 400.

Mechanically Detectable Indicator Patterns

In this example, the test strip is elongate and has a top major surface and
a bottom major surface. The test strip contains an indicator comprising zero or

WO 00/33074

PCT/US99/2731 I

more projections on the bottom major surface thereof. The projection(s), if any,
mechanically engage at least one pin in the test port. In the embodiment
illustrated in FIGS. 2a-2d, the indicator pattern is determined by the presence or
absence of projections in two specific locations. Upon insertion of the test strip
into the test port, the projection(s) mechanically engage a sensor comprising two
pins. In FIG. 2a, the indicator comprises two projections, which displace both
pins. In FIG. 2b, the indicator comprises only a first projection, with the second
projection is absent, resulting in only the first pin being displaced. In FIG. 2c, the
indicator comprises only a second projection, with the first projection absent,
resulting in only the second pin being displaced. In FIG. 2d, both projections are
absent and neither pin is displaced upon insertion of the test strip into the test
port.

In general, a test port that can detect projections or depressions at N
spots can recognize 2 N different indicators.

FIG. 5 depicts a cross section of a side view of a test port 500 engaged
with a test strip 520 having electrically conductive indicators. The test port 500
includes flexible pins 540 that can be biased into electrical communication with
relatively static pins 580 by an indicator 522 on the bottom major surface of the
test strip 520 when the test strip 520 is releasably engaged in the test port 500.
The test port 500 also includes assay electrodes 560 that are brought into
electrical communication with the top major surface of the test strip 520 when the
test strip 520 is releasably engaged in the test port 500.

Optically Detectable Indicator Patterns

As in the previous examples, the test strip is elongate and has a top major
surface and a bottom major surface. A printed pattern is on the bottom major
surface of the test strip. In this example, the test port has two optical sensors

WO 00/33074

PCT/US99/273I1

capable of detecting the presence or absence of a printed pattern at two different
locations on the bottom major surface of the test strip by measuring absorbance
and/or reflectance of light at those locations. As illustrated in FIG. 3, this
example allows for four (4) different configurations: (a) both locations "off, (b)
first location "on" and second location "off 1 , (c) first location "off' and second
location "on", and (d) both locations "on".

In general, a test port that can optically detect absorbance and/or
reflectance at N locations can recognize 2 N different configurations of indicators.

Resistance-based Indicators

As in the previous examples, the test strip is elongate and has a top major
surface and a bottom major surface. An indicator is on the bottom major surface
of the test strip. In this example, the test port has two electrically conductive
pins, which are bridged by the bottom major surface of the test strip when the
test strip is releasably engaged in the test port. The measuring device is capable
of measuring the resistance across the pins. The resistance measured can
serve to indicate the type of test strip being used. If the support material is non-
conductive, the lack of an additional indicator material can serve as a "null"
indicator.

In general, a test port that measures resistance can recognize an
arbitrarily large number of different indicators. The test port is limited only by its
capacity to distinguish between gradations in resistance.

Equivalents

The invention may be embodied in other specific forms without departing
from the spirit or essential characteristics thereof. The foregoing embodiments
are therefore to be considered in all respects illustrative rather than limiting on

WO 00/33074

PCT/US99/273U

the invention described herein. The scope of the invention is therefore indicated
by the appended claims rather than by the foregoing description, and all changes
which come within the meaning and range of equivalency of the claims are
therefore intended to be embraced thereby.

WO 00/33074

PCT/US99/2731 1

What is claimed is:

1 . A test strip for chemical analysis of a sample, adapted for use in
combination with a measuring device having a test port and capable of
performing a multiplicity of testing functionalities, said test strip comprising:

(a) a support capable of releasably engaging said test port;

(b) at least one reaction area on said support for receiving said
sample; and

(c) an indicator capable of interacting with said test port to select at
least one of said multiplicity of testing functionalities of said measuring device.

2. The test strip of claim 1 , wherein said indicator comprises one or
more electrically conductive indicator contacts capable of engaging at least two
electrically conductive pins within said test port, thereby selecting at least one of
said multiplicity of testing functionalities of said measuring device.

3. The test strip of claim 1 , wherein said indicator comprises one or
more electrically conductive indicator contacts capable of engaging at least two
electrically conductive pins within said test port, thereby closing a circuit between
said at least two electrically conductive pins, thereby selecting at least one of
said multiplicity of testing functionalities of said measuring device.

4. The test strip of claim 1 , wherein said indicator comprises one or
more projections on said support capable of mechanically engaging one or more
pins within said test port, thereby selecting at least one of said multiplicity of
testing functionalities of said measuring device.

5. The test strip of ciaim 4, wherein said projections displace one or
more of said pins.

WO 00/33074

PCT/US99/2731 1

6. The test strip of claim 1 , wherein said indicator comprises one or
more depressions on said support capable of mechanically engaging one or
more pins within said test port, thereby selecting at least one of said multiplicity
of testing functionalities of said measuring device.

7. The test strip of claim 6, wherein one or more of said pins may be
displaced into said depressions.

8. The test strip of claim 6, wherein said depressions define one or
more holes.

9. The test strip of claim 1 , wherein said indicator comprises an
optically detectable pattern capable of signaling or being detected by an optical
detector in said test port, thereby selecting at least one of said multiplicity of
testing functionalities of said measuring device.

10. The test strip of claim 2, wherein said indicator contacts comprise a
material selected from the group consisting of carbon, gold, silver, platinum,
nickel, palladium, titanium, copper, and lead.

1 1 . The test strip of claim 10, wherein said material is a printable ink.

1 2. The test strip of claim 1 , wherein said sample is a bodily fluid.

13. The test strip of claim 1 , wherein said chemical analysis comprises
measuring in said sample the concentration of a compound selected from the
group consisting of L-amino acids, alcohols, aldehydes, ketones, urea,
creatinine, xanthines, sarcosine, glucolate, pyruvate, lactate, fructosamine,
methylamine, carbon monoxide, cholesterol, hemoglobin, glycated hemoglobin,
microalbumin, high density lipoproteins, and low density lipoproteins.

WO 00/33074

PCT/US99/2731 1

14. The test strip of claim 1 , wherein said compound is glucose.

15. The test strip of claim 1 t wherein said reaction area comprises one
or more reagents adsorbed to said support, said reagent capable of reacting with
a compound in said sample.

1 6. The test strip of claim 1 5, wherein said reagent is selected from the
group consisting of glucose oxidase, lactate dehydrogenase, peroxidase, and
galactose oxidase.

1 7. The test strip of claim 1 , further comprising a multiplicity of
electrically conductive testing contacts capable of transferring current between
said reaction area and said measuring device.

1 8. The test strip of claim 1 7, wherein said testing contacts comprise a
material selected from the group consisting of carbon, gold, silver, platinum,
nickel, palladium, titanium, copper and lead.

1 9. The test strip of claim 1 8, wherein said material is a printable ink.

20. The test strip of claim 17, wherein said testing contacts are located
on a first major surface of said test strip and said indicator contacts are located
on a second major surface of said test strip.

21. The test strip of claim 17, wherein said testing contacts and said
indicator contacts are located on the same surface of said test strip.

22. A test port for use in a measuring device capable of performing a
multiplicity of testing functionalities and adapted for use in combination with a
multiplicity of different types of test strips, each of said types of test strips

WO 00/33074

PCT/US99/27311

corresponding to at least one of said testing functionalities, and at least some of
said types of test strips having indicators of said testing functionality thereon,
said port comprising a sensor capable of specifically interacting with said
indicators on said test strips, thereby selecting at least one of said multiplicity of
testing functionalities corresponding to a test strip.

The test port of claim 22, wherein said indicators are electrically
and said sensor comprises a multiplicity of electrically conductive

The test port of claim 23, wherein at least two of said electrically
pins may be bridged by said indicators, thereby closing an electrical

The test port of claim 22, wherein said indicators comprise
or depressions on said test strips and said sensor is a mechanical

26. The test port of claim 25, wherein at least a portion of said
mechanical sensor may be physically displaced by said indicators, thereby either
closing an electrical circuit or opening an electrical circuit.

27. The test port of claim 22, wherein said indicators are optically
detectable and said sensor is an optical sensor.

28. A measuring device having a multiplicity of testing functionalities for
chemical analysis, adapted for use in combination with a multiplicity of different
types of test strips, each of said types of test strips corresponding to at least one
of said testing functionalities, and at least some of said types of test strips having
indicators of said testing functionality thereon, said device comprising: .

23.

conductive
pins.

24.

conductive
circuit.

25.

projections
sensor,

WO 00/33074

PCT/US99/27311

(a) a test port comprising a sensor capable of interacting with said
indicators on said test strips to select at least one of said multiplicity of testing
functionalities; and

(b) a multiplicity of test circuitries for specifically measuring reactions
on said test strips corresponding to said multiplicity of testing functionalities.

WO 00A33074

PCT/US99/2731 J

1/4

FIG. 1A

FIG. IB

FIG. 1C

FIG. ID

FIG. IE

WO 00/33074

PCT/US99/27311

2/4

FIG. 3A

□

FIG. 3B

FIG. 3C

FIG. 3D

WO 00/33074

PCT/US99/2731 1-

4/4

CM •

INTERNATIONAL SEARCH REPORT

Inter ^nal Application No

PCT/US 99/27311

A. CLASSIFICATION OF SUBJECT MATTER ,

IPC 7 G01N33/52 B01L3/00

According to International Patent Classification (IPC) or to both national class! ficatlon and IPC

B. FIELDS SEARCHED

Minimum documentation searched (classification system followed by classification symbols)

IPC 7 G01N BOIL

Documentation searched other than minimum documentation to the eident that auch documents are Included in the fields searched

Electronic data base consulted during the International search (name ol data base and, where practical, search terms used)

C. DOCUMENTS CONSIDERED TO BE RELEVANT

Category • Citation ol document, with indication, where appropriate, ol the relevant passages

Relevant to claim No.

4; claims

WO 96 13707 A (CONNOLLY JAMES)
9 May 1996 (1996-05-09)

page 3, line 12 -page 4, line "22
page 6, line 23 -page 7, line 22
page 9, line 7 -page 15, line 25
page 18, line 3 -page 19, line 4

US 5 281 395 A (MARK ART ERNST ET AL)
25 January 1994 (1994-01-25)

the whole document

WO 98 05424 A (CHOW CALVIN Y H ;CALIPER
TECHN CORP (US) )
12 February 1998 (1998-02-12)
claims; figures

-/~

1,9,

13-16,

22,27,28

1,9,12,

15,22,

27,28

1,22,27,
28

X Further documents are listed in the continuation of box C.

Patent family members are listed in annex.

• Special categories of cited documents :

"A" document defining the general state of the art which is not •
considered to be of particular relevance

"E" earlier document but published on or after the international
filing date

"L" document which may throw doubts on priority claim(s) or
which is cited to establish the publication date ol another
citation or other special reason (as speed led)

"O" document referring to an oral disclosure, use, exhibition or
other means

"P" document published prior to the international filing date but
later than the priority date claimed

T later document published after the International filing date
or priority date and not in conflict with the application but
cited to understand the principle or theory underlying the
invention

"X" document of particular relevance; the claimed invention
cannot be considered novel or cannot be considered to
involve an inventive step when the document is taken alone

"Y" document of particular relevance: the claimed invention

cannot be considered to involve an inventive step when the
document is combined with one or more other such docu-
ments, such combination being obvious to a person skilled
in the art.

"&' document member of the same patent family

Data of the actual completion of the international search

21 March 2000

Date ot mailing of the International search report

29/03/2000

Name and mailing address of the ISA

European Patent Office. P.B. 5818 Patentlaan 2
NL - 2280 HV Ri]swijk
Tel. (+31-70) 340-2040. Tx. 31 651 epo nl,
Fax: (+31-70) 340-3016

Authorized officer

Luzzatto, E

Foim PCT/tSA/210 (second shoel) (July 1992)

page 1 of 2

INTERNATIONAL SEARCH REPORT

Into .onal Application No

PCT/US 99/27311

C.<Continuation) DOCUMENTS CONSIDERED TO BE RELEVANT

Category • Citation ot document, with indlcatton.where appropriate, of the relevant passages

Relevant to dalm No.

EP 0 837 320 A (BAYER AG)

22 April 1998 (1998-04-22)

column 4, line 35 -column 8, line 30;

claims

GB 2 254 436 A (WILSON ROBERT)

7 October 1992 (1992-10-07)

whole document, esp. p. 4, 1. 23-26 and

claims

EP 0 840 122 A (BAYER AG)

6 May 1998 (1998-05-06)

column 4, line 7 -column 5, line 44;

claims; figures 3,4

EP 0 006 031 A (EASTMAN KODAK CO)
12 December 1979 (1979-12-12)
page 2, line 14 -page 3, line 17
page 6, line 5 - line 35; claims

EP 0 351 891 A (MEDISENSE INC)
24 January 1990 (1990-01-24)
abstract; claims

EP 0 377 503 A (EASTMAN KODAK CO)
11 July 1990. (1990-07-11)
the whole document

EP 0 567 067 A (FUJI PHOTO FILM CO LTD)

27 October 1993 (1993-10-27)

column 14, line 41 - line 49; claims

1,9,15,
22,27,28

1,28

4-8,25,
28

10,11

4-8,25,
26

Form PCT/lSA/210 (continuation of second sheet) (July 1992)

page 2 of

INTERNATIONAL SEARCH REPORT

Information on patent family members

trttet anal Application No

PCT/US 99/27311

Patent document

Publication

Patent family

Publication

cited in search report

date

member(s)

date

WO 9613707

09-05-1996

US 5597532 A
DE 69511533 0
EP 0750739 A

28-01-1997
23-09-1999
02-01-1997

US 5281395 A 25-01-1994

4041905 A

02-

-07-

-1992

119292 T

15-

-03-

-1995

59104792 D

06-

-04-

-1995

0492326 A

01-

-07-

•1992

2071198 f

16-

-06-

-1995

3015727 T

31-

-07-

-1995

7005109 A

10-

-01-

•1995

7035998 B

• 19-

-04-

•1995

W0 9805424 A 12-02-1998 AU 3815697 A . 25-02-1998

CA 2259929 A 12-02-1998

CN 1226845 A 25-08-1999

EP 0952890 A 03-11-1999

US 5955028 A 21-09-1999

EP 0837320 A 22-04-1998

US
AU
CA
OP
NO

5945341
4190097
2216678
10132734
972724

GB 2254436 A 07-10-1992

EP
W0
JP

0578669 A
9217778 A
6506144 T

31-08-1999
23-04-1998

21- 04-1998

22- 05-1998
22-04-1998

19-01-1994
15-10-1992
14-07-1994

EP 0840122 A 06-05-1998

US
AU
CA
JP
NO

5856195
4357897
2217312
10132777
973220

05-01-1999
07-05-1998
30-04-1998
22-05-1998
04-05-1998

EP 0006031 A 12-12-1979 US 4279861 A 21-07-1981

US 4142863 A 06-03-1979

JP 1353407 C 11-12-1986

JP 54160296 A 18-12-1979

JP 61018986 B 15-05-1986

US RE30595 E 28-04-1981

EP 0351891 A 24-01-1990

Form PCT/1SA/210 (patem tamAy annex) (July 1 992)

2154003

29-08-1985

572138

05-05-1988

2775584

08-11-1984

1226036

25-08-1987

3485554

16-04-1992

3486221

04-11-1993

3486221

27-01-1994

0127958

12-12-1984

0351892

24-01-1990

9325127

16-12-1997

7072727

02-08-1995

60017344

29-01-1985

5682884

04-11-1997

5727548

17-03-1998

5820551

13-10-1998

616169

24-10-1991

page 1 of 2

INTERNATIONAL SEARCH REPORT

Information on patent family members

Inti .lonal Application No

PCT/US 99/27311

Patent document

Publication

Patent family

Publication

cited in search report

date

member{s)

date

EP 0351891

1239188

07-07-1988

5509410

23-04-1996

569076

21-01-1988

2775384

08-11-1984

580257

12-01-1989

2775484

08-11-1984

1219040

10-03-1987

1223638

30-06-1987

1218704

03-03-1987

1220818

21-04-1987

0125867

21-11-1984

0125136

i A 11 1 An Jl

14-11-1984 !

0125137

14-11-1984

0125139

14-11-1984

4758323

19-07-1988

4711245

08-12-1987

EP 0377503

11-07-1990

4948737

14-08-1990

2231542

13-09-1990

EP 0567067

27-10-1993

2903273

07-06-1999

6213903

05-08-1994

69319272

30-07-1998

69319272 T

05-11-1998

5538688 A

23-07-1996

Form PCT/ISA/210 (patent family annex) (July 1992)

page 2 of 2

Internet Archive Audio

Featured

Top

Images

Featured

Top

Software

Featured

Top

Books

Featured

Top

Video

Featured

Top

Mobile Apps

Browser Extensions

Archive-It Subscription

Save Page Now

Full text of "USPTO Patents Application 10687850"

See other formats